- Todos > Medicine Information and Evidence for Policy > Medicines Policy
- Todos > Medicine Access and Rational Use > Rational Use
- Todos > Quality and Safety: Medicines > Safety and Efficacy
- Palabras clave > adverse drug reactions (ADRs)
- Palabras clave > adverse event (AE)
- Palabras clave > pharmacist
- Palabras clave > pharmacist - role
- Palabras clave > pharmacist practitioner - surveillance of medicines
- Palabras clave > pharmacovigilance
- Palabras clave > post marketing surveillance
- Palabras clave > safety
- Palabras clave > farmacéutico
(2006; 4 pages) [French] [Spanish]
The World Health Organization (WHO) defines pharmacovigilance as "the science and activities relating to the detection, assessment, understanding and prevention of adverse affects or any other possible drug-related problems."
Modern medicines have changed the way in which diseases are managed. Safety monitoring of medicines is an integral part of clinical practice. In providing high quality medical care, safety monitoring is essential to the ongoing effective use of medicines, Pharmacovigilance is recognised as a clinical discipline and it serves as an indicator of the standards of clinical care practised within a country.
Approval for a medicine is based on controlled and regulated clinical trials. Once an approved medicine is placed on the market, it leaves the controlled scientific environment of clinical trials. At this point, most medicines will only have been tested for short-term safety and efficacy on a limited number of carefully selected individuals. Therefore, it is important that the use of these medicines is monitored for their ongoing effectiveness and safety. Pharmacists have an important responsibility in monitoring the ongoing safety of medicines.